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Regulatory Affairs Manager

New Jersey All, NJ

Posted: 08/23/2019 Job Type: Scientific Job Number: JN -082019-25484

POSITION OVERVIEW/SUMMARY

The Regulatory Affairs Manager (Consultant) will participate in the preparation of regulatory submissions and manage related requirements and timelines. The incumbent will interact closely with a range of internal and external partners including Regulatory Operations, Clinical Operation, Contract Research Organization (CRO), and Clinical Supply on a range of regulatory activities related to clinical studies.


QUALIFICATIONS

Education:

Bachelor's degree in scientific discipline or related field required


Professional Experience:

Minimum of 5-7 years of experience in the industry with at least 3-5 years in Regulatory Affairs.

Experience working in a multicultural, multi-lingual environment.


Knowledge and Skills:

In-depth knowledge of the regulatory submissions process and related FDA regulations.

Strong organizational skills coupled with a sense of urgency; proven ability to manage processes to timeline.

Excellent interpersonal and cross-functional collaboration skills.

Strong attention to detail; a track record of error-free FDA submissions.

Competency in MS Office and Documentum

Willingness to travel up to 5%

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